BD · 1 month ago
Manufacturing Quality Engineer
Columbus, NE
Full-time
Onsite
Mid Level
3+ years expBD is one of the largest global medical technology companies in the world, dedicated to advancing the world of health. The Manufacturing Quality Engineer will assist the Manufacturing Departments in establishing and implementing quality control programs, using problem-solving techniques to enhance quality and productivity while ensuring compliance with safety regulations.
Health CareMedical DeviceTechnical Support
Responsibilities
Develop, change, and supervise in-process inspections to ensure the greatest value in process control for the customer and the plant during the manufacturing process while meeting regulatory requirements
Process monitoring and adjustment, process and product improvement, including corrective action plans to address complaint issues
Documentation of these activities along with the review and maintenance of S.O., O.I.s and department specific operating procedures such as manufacturing cleaning procedures
Employee training of Quality Control concerns regarding Process specifications
Develop and implement procedures applicable to the total plant manufacturing process
Coordinate efforts with Process Engineering, Production for the establishment of controls, which support current product designs, and process capabilities for assigned product lines. Assistance in such areas as process validation, process acceptance, certain audit correction actions, Change Control issuance for process changes
Support CAPAs as owner or as part of the support team
Moniitor the performance of assigned product lines about product quality levels, waste, and rejection rates
Leading / mentoring / conducting quality improvement projects thru CI initiatives
May acquire Green/Black Belt Certification
Assist in the acceptance and validation of process / equipment
Review and develop changes in existing or proposed processes or requirements to achieve optimum performance and quality, cost
Assume a role of leadership in analyzing and resolving issues, which prevent desired quality levels achievement
Develop programs for the maintenance, replacement, and improvement of inspection gauging
Stay informed as to the latest requirements of federal regulations and corporate policies regarding medical devices
Lead and ensure regulatory compliance is met and that the manufacturing unit is trained on all requirements
Own and continue to improve department training systems
Monitor customer complaints and trends. Respond as needed for specific corrective action and customer interface
Provide support and guidance on quality/ process improvements
Ensure that all company safety rules and regulations are followed and promote general plant safety
Own and lead efforts to reduce and eliminate rejections
Assist in internal/ external audits and supplier certification processes as needed
Other duties as required to support the needs of the business
Qualification
Required
Bachelor's degree required
Three years manufacturing experience with broad background in manufacturing process
Two years Process Control experience
Three years practical GMP/Medical Device manufacturing experience
Effective Oral/written Communication - Proficient
Ability to work as part of a team / Teambuilding - Advanced
Independent thinking / Self Driven - Proficient
Decision Making Ability - Proficient
Computer Skills / Microsoft Office - Proficient
eDHR related software
Product / process improvements utilizing Green/ Black Belt/Six Sigma techniques
Ability to generate validation protocols, which align with the globalization standardization initiative
Preferred
May acquire Green/Black Belt Certification
Benefits
Competitive pay
Access a portion of your pay before pay day with DailyPay
Healthcare coverage: No paycheck contributions for eligible associates under a certain salary threshold enrolled in the HSA Basic Medical Plan option, no matter how many dependents you cover.
Preventive care covered at 100%.
Dental and vision insurance at group rates.
Paid parental leave up to 6 weeks
Adoption assistance plan
401(k) plan with 75 cents on the dollar matched by BD up to 6% of compensation
Company paid basic life and AD&D insurance
Tuition reimbursement
Discounted home, auto and pet insurance
Paid holidays and vacation (pro-rated the first year based on actual start date)
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Maureen Mazurek
Chief Sustainability and EHS Officer
Recent News
EIN Presswire
2026-01-09
Company data provided by crunchbase